JA_IAAwithHHS_BDVeritorCOVID_Multiplex_FINAL_11Jan22(an)(jh)(cdp)_REDACTED_Redacted.pdf

Control Number: 36C10X21R0084-001

Source Selection Information � See FAR 2.101 and 3.104

COVID-19 test kits to support these vulnerable populations, as directed by the President on September 9, 2021.

Further, the use of VA acquisition support is absolutely critical in meeting this urgent and compelling federal need due to the recent spike in COVID-19 cases across the globe. According to the Center for Disease Control (CDC), in the U.S. alone, it is expected that in the month of September 5,800 � 18,600 new deaths will be reported and 550K�1.6M new COVID-19 cases are expected. In addition, the number of jurisdictions reporting increases in COVID-19 cases is up 70% from week to week. The increase in cases indicates that at least some COVID-19 variants are much more infectious (e.g., the Delta Variant) and is leading to increased transmissibility when compared with previous variants, even in some vaccinated individuals. This effort supports the President of the U.S. September 9, 2021 announcement to rapidly �mobilize industry due to the urgent and compelling need to accelerate the production of rapid COVID-19 tests� and �will be available to support a range of needs, including long-term care facilities, community testing sites, critical infrastructure, shelters serving individuals experiencing homelessness, prisons and jails, and other vulnerable populations.� The FQHC locations support a key vulnerable population, which often has low COVID19 vaccination rates (30-40%) and live-in congregate settings. Therefore, this prescribed testing activity in response to COVID-19 is considered an urgent and compelling need to support the containment and recovery of the outbreak in underserved communities throughout the country.

Lastly, due to the evolving nature of the COVID-19 virus into more contagious, rapidly spreading variants, it is prudent to have adequate flexibility of testing capabilities to address associated public health emergencies. The intent of this action is to establish a one-time contract between VA, on behalf of DHHS and Becton, Dickinson and Company (BD), in direct support of the Health Resources and Services Administration (HRSA) mission to provide a single capability that can provide COVID-19 and Flu A & B testing to FQHC locations nation-wide. When the COVID-19 pandemic swept the world in March 2020, the significant supply chain shortfalls were emphasized and manufacturers supporting the healthcare crisis realized production lines were unable to keep up with the increasing pace of demand. Unable to meet customer demand, BD implemented an allocation strategy equipped to support the DHHS requirement. The FQHC locations service low-income demographics, who have historical low vaccination rates, for a variety of diseases. BD manufactures this critical combo assay test that can fill a void in testing for this key vulnerable population.

3. Description of Supplies or Services:

The DHHS has an urgent need to contract for testing capability to support approximately 1,500 FQHC locations in rural communities nationwide, for 2.5 million people monthly. The FQHCs require testing capabilities that test for COVID-19 but also test for influenza (virus A & B), diseases prevalent in the communities serviced by FQHC locations. Currently, BD is the only company that provides a single rapid test capability to address both diseases to meet the supply and demand timeline required by the DHHS. Specifically, FQHC locations have a requirement for 3.8 million SARS-COV- 2 tests and 3,000 Assay Device Units in the next 60 days, and 15 million SARS- COV2/FLU A/B tests between 90 and 200 days.

The BD Veritor� Plus System platform has previously been clinically accepted and utilized by the DHHS to support rapid, qualitative detection and differentiation of SARS- CoV-2, the virus that causes COVID-19. The BD Veritor� Plus System platform includes two types of tests: SARS-CoV2/Flu A&B combo assay test and SARS-CoV-2 test. The SARS-CoV2/Flu A&B combo assay test offers rapid actionable detection of SARS-CoV-2 and Flu A & B in as little as 25 minutes. The SARS-CoV-2 test provides rapid detection of the current coronavirus SARS-CoV-2 in as soon as 30 minutes, for positive results.

At this point and time, BD is the only known source with the capability with emergency use authorization (EUA) to produce and distribute the required volume of multi-faceted tests which can be used for COVID-19, as well as, Influenza (virus A & B), mirroring the CDC initiative toward multiplex Assay development. The BD Veritor� Plus System platform affords the FQHC locations the best capability to meet the multiple needs of their underserved communities within this aggressively short timeline. Further, FQHC locations are familiar with the BD testing capabilities; procuring from another private source under such a compressed timeline would produce a steep learning curve counter to the unusual and compelling need of this national crisis.

The BD Veritor� Plus System platform delivers accurate (with 98% overall percent agreement), reliable and rapid results in a matter of minutes across a menu of respiratory tract infection assays including SARS-CoV-2 (COVID-19) and Flu A & B.

The rapid and digitally read BD Veritor� Plus System provides unambiguous results and helps users have clarity and confidence in their testing, leaving no room for misinterpretation (as compared to visually read tests). Simple-to-use and intuitive, the device does the hard work, making it ideal for under-resourced, stationary facilities. It corrects for non-specific binding and uses advanced particle technology to enhance sensitivity and detect positive results unrecognizable by the unaided eye. The BD Veritor� Plus System provides a reliable, objective answer at the click of its one button.

Beyond COVID-19, community health centers can continue to support the most underserved with point-of-care capabilities of the BD Veritor� Plus System that go beyond SARS-CoV-2 to other important respiratory tract infections.

The delivery schedule for the resultant contract issued under the authority of this justification is currently expected to begin January 31, 2022 through April 30, 2022 based on production and accounting for unforeseen interruptions, but will not extend beyond 12 months period of performance. The resulting award will provide critical coverage while affording DHHS the requisite time to establish their own long-term procurement vehicles. The resultant contract will be awarded as a FFP vehicle, with an estimated total contract value of .

4. Statutory Authority:

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-2 entitled, �Unusual and compelling urgency�, to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19) and any associated respiratory illnesses such as FLU A & B.

5. Rationale Supporting Use of Authority Cited Above:

On March 13, 2020, the President declared the COVID-19 pandemic a national emergency. As a result, the sudden and massive increase in testing has resulted in a shortage of both COVID-19 analyzers and their accompanying accessories. As this worldwide pandemic continues, all available testing and diagnostic supplies are in high demand and the market for these supplies is highly volatile.

The supplies required are in support of expanded testing and diagnostics capabilities across the nation in targeted communities, supporting economically disadvantaged and vulnerable populations, while minimizing COVID19 spread in communal living. The proposed monthly support leverages previous DHHS Defense Production Act investment to expand testing capability and capacity in response to COVID-19.

Implementing a community center testing strategy using the BD Veritor� Plus System platform minimizes waste of critical national test supplies, increases and diversifies community access to testing, and sustains national testing capabilities. Additionally, equipping community health centers with the BD Veritor� Plus System platform enhances their capability to provide community support beyond COVID-19 since the testing platform can be used to test for multiple illnesses. Use of the BD Veritor� Plus System platform also frees other USG testing assets and supplies for priority programs such as border and school testing.

Public health requires the continued acquisition of these testing supplies in order to effectively diagnose low-income citizens nationwide. Current U.S. production capacity and existing supply of COVID-19 analysis machines and accessories is so inadequate that on March 23, 2020, the President issued Executive Order 13910 on Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19, delegating to VA the authority to enforce. Failure to immediately execute a contract on behalf of DHHS to support the 1,500 FQHC locations will only leave the Government and the nation critically unprepared for the current COVID-19 virus and the next unknown variant or pandemic emergency.

The recent spikes in infections and lack of vaccination in low-income areas have caused surges in demands for testing, which have exceeded available quantities of previously procured tests. Given the fact that the demand has surpassed the available supply, continued procurement for COVID-19 test kits is needed in order for DHHS to continue meeting its national mission nationwide.

VA Acquisition Policy Flash! 20-27 discusses VA Procedures, Guidance and Instructions M818, Emergency Acquisitions, and use of the Federal Emergency Management Agency (FEMA) disaster declaration website for approved calendar dates for National Emergencies. According to this FEMA website as verified on December 22, 2021, the COVID-19 Emergency Declaration was declared on March 13, 2020, with �Incident Period: January 20, 2020 and continuing�. Approval of this individual justification enables DHHS to avoid delays in providing vital COVID-19 rapid testing and the catastrophic negative impact to our nation�s citizens. Should the COVID-19 pandemic be controlled or eradicated through available vaccines or immunity, the BD Veritor� Plus System platform can also be utilized for FLU A/B and RSV testing, thereby preventing any potential waste.

6. Efforts to Obtain Competition:

The overall mission of DHHS is to assess and identify test capabilities that best respond to the COVID-19 effort and other associated national testing requirements. Through the review and analysis of multiple test platforms and an extensive effort to align the best test capability to vulnerable communities in such a quick timeframe, DHHS, in collaboration with HRSA, identified the BD Veritor� Plus System platform as the best capability to meet the timeframe and volume of this unusual and compelling urgency.

This effort did not yield any additional sources that can meet the Government�s requirements.

As confirmed through market research, the proprietary nature of BD testing materials results in noncompatibility with other instruments. The fact that this effort is to support a one-time emergency need for DHHS, coupled with the unprecedented and unforeseen circumstances of current surges in variants that arose during the COVID-19 pandemic, it is not practical to seek full and open competition for this volume of urgently needed COVID-19 diagnostic equipment/test kits.

As increased global demand on the worldwide supply chain continues to result in acute global shortages, DHHS is exercising due diligence in continuing to validate the source of supply; obtaining medical-field subject matter expertise to determine if the offered equipment will meet the needs of the Government; validating the need for the offered test kits; ensuring the price is reasonable; and, is making appropriate contractor responsibility determinations prior to issuing any resultant contract award.

In accordance with FAR 5.202(a)(2), the Contracting Officer did not submit the notice required by FAR 5.201 because the Contracting Officer has determined that the proposed contract action is made under the conditions described in FAR 6.302-2 and the Government would have been seriously injured if the agency complied with the time periods specified in FAR 5.203.

7. Contracting Officer determination that the anticipated cost to the Government will be Fair and Reasonable:

No award shall be made under the authority of this justification until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, past proposal submissions, and market research other information made available utilizing price analysis for the BD Veritor� Plus System platform. A search of the System for Award Management database concluded there were no restrictions in place that would limit the Government from contracting with BD.

BD submitted pricing for Veritor� Plus System platform in accordance with the table below:

Item #

OEM

Part # Description

1 256066 BD Veritor Plus System Analyzer

2 256082 BD Veritor Plus System Rapid Detection Kit

3 256088 SARS CoV2 Assay 4 N/A Technical Support 5 N/A Training 6 N/A Shipping and

Logistics

8. Market Research:

Market research was conducted by DHHS and the Contracting Officer to determine the suitability of commercial items and it has been determined that the Government�s needs may be met by a type of item customarily available in the commercial marketplace that would meet the definition of a commercial item(s) in accordance with FAR 2.101 and 10.002. Market research consisted of a recheck and revalidation of supply and procurement sites, market conditions as well as analysis of prior purchase prices as detailed in paragraph 7 above.

The VetBiz.gov database was accessed on December 22, 2021. This search did not produce any registered, certified, and qualified Service-disabled Veteran-owned Small Businesses (SDVOSBs) or Veteran-owned Small Business (VOSB) in accordance with the federal small business size standard for the applicable North American Industry Classification System Code (339112, Surgical & Medical Instrument Manufacturing) and the Federal Supply Class (6515, Medical, Surgical Instruments, Equipment and Supplies). However, as the BD Veritor� Plus System platform SARS-CoV-2 and SARS-CoV-2/Flu A&B test kits is propriety and has no authorized SDVOSB or VOSB distributors, the SDVOSB/VOSBs are not considered for this procurement.

The requirement is to obtain rapid testing capabilities for COVID-19, that deliver accurate results across a menu of respiratory tract infection assays including SARS- CoV-2 (COVID-19) and Flu A & B. The test should be digitally read, simple-to-use and intuitive, and have reporting capabilities, thus making it ideal for under-resourced, stationary facilities, such as FQHC locations. Of the currently approved rapid testing technologies on the market, BD stands out as the competitively priced and immediately available at the required quantity.

The program has completed a thorough review of FDA�s In Vitro Diagnostic (IVD) EUA website lists all technologies currently EUA authorized. Only a small subset has multiplex capabilities and of those tests, an analysis and engagement with industry was performed on which tests could provide the multi-plex capability desired, ease-of-use, rapid and digitally read results, and reporting that would work and importantly integrate seamlessly into FQHCs, which are resource-constrained.

9. Other Facts:

The VA has previously supported FEMA and DHHS with the delivery of medical supplies and coordination of support missions in response-to and recovery-from nationally declared emergencies and disasters. Given that VA Medical Centers and other select federal facilities are designated DHHS facilities with significant contingency and emergency response roles, the failure to rapidly acquire COVID-19 and multi-test kits would not only negatively impact healthcare delivery to our nation�s Veterans and their dependents, but also potentially have a direct negative impact on the greater public.

As a whole of government approach, the DHHS Testing and Diagnostics Working Group (TDWG) is working diligently to establish a long-term strategy to supply under-represented communities with adequate testing supplies while employing and sustaining the current testing infrastructure. Based on the environment being covered, the BD Veritor� Plus System platform is best matched to community health centers.

Community Health Centers are familiar with the BD test and their operations are in non-mobile facilities for which the BD Veritor� Plus System platform is ideal. Other test platforms are being assessed and considered for other vulnerable markets.

10. Other Interested Sources: Not Applicable

11. Actions to Increase Competition:

The DHHS continues to conduct market research and evaluate new test and diagnostic sources and capabilities to ascertain if there are changes in the marketplace that would enable future actions of similar nature to be competed under such short notice. The DHHS continues to encourage companies to develop testing capabilities that will test for multiple diseases and in a rapid fashion. Additionally, the Government is executing several different test programs that will span across several contractors currently operating with the test market, enhancing the U.S.

domestic industrial base. Investing in the domestic industrial base encourages the development of innovative technologies which will greatly enhance testing capabilities for the nation. Future requirements will be handled on a case-by-case basis to determine future acquisition strategy.

12. Procuring Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

13. Technical and Requirements Certification:

I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

AS3 22 074

Source Selection Information � See FAR 2.101 and 3.104

12. Fair and Reasonable Cost Determination:

As the Contracting Officer, I hereby determine that the anticipated cost to the Government of the resulting non-competitive contract award will be fair and reasonable based on the information herein. In negotiating pricing for the non-competitive contract, the Government will evaluate and approve associated delivery fees based on comparison to previous years.

Concurrence

In my role as Head of the Contracting Activity, based on the forgoing justification, I hereby approve the award of a FFP contract award in support of DHHS and in accordance with FAR 6.302-2 entitled, �Unusual and Compelling Urgency,� subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.